The controversy surrounds a provision of the fix-up bill that requires radiologists to report the radiation dose in addition to the automatic reporting performed on a CT scanner, a measure many in the radiology community consider duplicative and error-prone.
The California Radiation Protection Act, introduced by a trial lawyers group and signed into law in September 2010 by then-Gov. Arnold Schwarzenegger, arose in response to several high-profile excessive radiation cases in 2009 that led to multiple lawsuits against hospitals in the state.
In July the act will take effect, requiring that physicians report excessive radiation doses to the California Department of Public Health. Its provisions are being carefully scrutinized, as the law is considered a potential model for national legislation on radiation dose protection, or at least for several other states that are considering legislation similar to California's.
A fix-up bill, AB 510, was written to clarify and modify several provisions of the original act that radiologists considered unwieldy or impractical. It's expected to clear both State houses following final debate on its provisions and land on Gov. Jerry Brown's desk for signature sometime around the first of the month or shortly thereafter, according to the California Radiological Society. The fix legislation will take effect as soon as the governor signs it, but that may not occur before the original law takes effect.
Controversy surrounding its passage isn't expected to arise so much between lawmakers, who are seen as deferring to the expertise of its stakeholders (e.g., the California Department of Public Health, which will oversee the law; the trial lawyers who initiated the original legislation; and the hospitals who must implement it), as it is between these stakeholders.
Nevertheless, beyond the dose-reporting disagreement, the individuals interviewed for this story seemed satisfied with what they consider AB 510's common-sense modifications to the original California Radiation Protection Act.
As for the next couple of weeks, "everybody knows what's coming -- we've had numerous meetings with the Department of Public Health, the regulatory body," as well as the trial lawyers represented by Consumer Attorneys of California (CAC) and the hospitals, said Robert Achermann, executive director of the California Radiological Society (CRS).
Now that these stakeholders are thought to be on the same page, the bill is being brought for final consideration in the legislature before being sent to the governor.
"We've been waiting for these final discussions to make sure that what amendments occur to the law are acceptable to the [Brown] administration; we don't want the bill to be vetoed," Achermann said. California state agencies such as the Department of Public Health don't typically take positions on legislation but rather provide technical assistance, he added.
"The law itself, if you read all the gory details, is not that onerous," said medical physicist John Boone, PhD, professor and vice chair of radiology and professor of biomedical imaging at the University of California, Davis, in an interview. "The dose thresholds that would require reporting are very high and would be rarely exceeded in most practices."
Davis and his colleagues in the University of California system have been closely involved with the parties during the drafting of the original law and now the amendment.
Housekeeping amendments clarify language
Most of the changes envisioned by AB 510 are more akin to housecleaning measures that everyone believes are necessary. For example, a provision that triggered a report to the California Department of Public Health when anatomy other than the scanning target was irradiated has been modified to apply only when "unintended" areas are irradiated.
AB 510's language eliminates previous concerns -- for example, that irradiating part of the lower chest in a scan targeting the abdomen would constitute an unavoidable yet reportable event.
Having to report the irradiation of normally contiguous scan areas to the state would be "silly -- that's just part of what we do," said Dr. Rebecca Smith-Bindman from University of California, San Francisco. With the new language, a report to the state of California would be generated only in the event of a "clear medical screw-up" such as irradiating the abdomen when the physician ordered a head scan, she said.
"If the intent of the examination was to cover that area -- be it a CT exam, be it applying radiation therapy -- there's no reporting required," Achermann noted.
Another provision of the original law stated that the dose report "shall" be sent to the PACS, which is impossible for facilities that don't have a PACS network. The current language says the information "may" be sent to the PACS, Achermann added.
In other changes from SB 1237, accreditation of CT systems won't be required for radiation therapy, when CT systems are used to calculate the attenuation coefficient for nuclear medicine studies, or when dedicated CT units are used for image guidance in interventional radiology. In any case, image-guidance systems can't be accredited because they don't have a study to evaluate, Achermann said.
"One of the odd things about this bill is that there is no maximum dose that cannot be exceeded," Achermann said. "The purpose of this bill was to prohibit excessive doses of radiation, but really so long as that's what you intended to do," no dose is too high as to generate a reportable event, he said.
"It's really reporting when you irradiate the wrong patient, the wrong anatomic area, or you repeat an examination that wasn't requested," he said.
Double dose reporting burden remains
Unfortunately from the CRS' point of view, language requiring radiologists to include dose information on the radiation report was never resolved acceptably with the trial attorneys, and as a result, the requirement is expected to remain in the final language, Achermann said.
SB 1237 stated that the dose information could either be put into the radiology report or the protocol page containing the information could be attached to the report. However, hospitals have come to read that provision as requiring that both dose inputs occur, leading to CRS' fervent efforts to change the language, Achermann said.
"We spent a lot of time arguing that point, but the trial attorneys were very resistant to any change," he said. "They felt that the radiologist dictating the dose into the report, and the referring physician seeing the dose in the report, would all be helpful in minimizing the risk of excessive radiation exposure."
CRS explained to the attorney group that modern scanners report the dose information automatically; requiring the radiologist to dictate it into the report only creates an opportunity for error, Achermann said. That's because most CT systems don't have a way to populate the dose information automatically into the radiology report, so radiologists will have to dictate each case until such automated systems can be developed, purchased, and implemented statewide.
Software developers will certainly develop methods to accommodate the requirement and populate the dose information in the report automatically, and comprehensive dose-tracking applications will eventually render the requirement obsolete by recording patients' cumulative radiation doses from scans. Indeed, they are actively engaged in the development of such systems, he said, but for now the lack of workable systems is generating double work that is prone to inaccuracy.
For her part, Smith-Bindman told AuntMinnie.com that she does strongly support dose reporting within the radiology report, however it occurs, because dose awareness yields so many benefits. While conceding that the lack of current technological solutions is a problem, she said that development of such solutions is urgent work that needs to be done.
Putting every scan dose into the radiology report offers "an enormous amount to be gained, in terms of increasing awareness of radiation dose, from the patient and referring provider's point of view, as well as from the radiology physician doing the study who has to look at it to report it," Smith-Bindman said. "And if it's a nonradiologist doing the exam, such as a cardiologist, an orthopedic surgeon, or a urologist, there is the same level of increased awareness from having to look at these data."
Smith-Bindman conceded that she's no fan of manual entry of dose data, even temporarily, but said the benefits are compelling. "For the safety of our patients, we need to find a solution for that, rather than saying it doesn't need to be done," she said.
Simply stating that CT scanners already provide dose information is misleading, she said. A big problem currently is that scanners don't automatically put the dose where it can be found by anyone who needs the information.
For example, CT scanners include dose information on the DICOM header and often on an image, but some facilities don't send that particular image to the PACS, or don't send it to the PACS in ways it can be viewed.
As a result, referring clinicians and patients often can't access the information, and even the radiologists don't look at it, she said.
"Yes, it's technically in the system somewhere, but it's extraordinarily difficult for anyone who wants to get hold of it for patient care to do so," she said. "I want to get it into a part of the patient's medical record that the patient and the physician have access to."
Too often, she said, patients requesting information about the radiation dose in a scan find that providers don't have the information and say they can't get it. Dictated reports, on the other hand, go out to the electronic medical record (EMR), the referring physician, and the patient, if he or she wants it, and are therefore a much more reliable place to put dose information, Smith-Bindman said.
But Boone countered that relying on manual dictation of dose information, even temporarily, is a bad way to start.
"People are in panic mode right now," he said. "A lot of institutions are going to have radiologists dictating [CT does index volume] and [dose-length product] into every CT case, which is not a viable long-term solution. The reality is that a human conveyance of numbers is never going to be very accurate, and it won't be something that you could go in and mine the data, so it doesn't really address the greater good."
Software, on the other hand, allows the development of mineable data for an institution that is very similar to the American College of Radiology's dose tracking tool, he said. Most University of California health systems have found a solution because they started looking for one years ago, when the radiation bill was being crafted.
"We can drill down and see what the average and standard deviation is for our head protocol, and for every CT protocol we have," he said. Using software, dose can be tracked by scanner, by technologist, enabling far greater oversight of actual radiation doses "as a result of the tool we've been forced to get," he said. "Frankly, it's something the industry should have done long ago."
Boone said that software would have alerted providers at Cedars-Sinai, for example, where in 2009 more than 250 patients received excessive radiation doses in CT perfusion studies of the head, in a case that led to the lawsuits that spurred passage of the Radiation Protection Act, he said.
But dictating dose levels manually? "A lot of managers are going to find their radiologists saying 'hell no -- I'm not going to do this,' or they're going to find other ways around it," Boone predicted. "Certainly our radiologists said, 'You want us to do what?' "
Smith-Bindman said the potential danger of excessive radiation is the more important concern.
"My personal opinion on this issue is that CT scanners are incredibly powerful machines, and when used appropriately they can really help our patients enormously with their diagnosis, and when misused, they have the capacity to cause real harm," she said. Every CT exam has to be justified, and that can't happen without knowing what dose will be delivered.
Currently, the ordering physicians and the radiologists conducting the exams have very little awareness of the doses they're using, and that's something that needs to change, according to Smith-Bindman.
"Our culture needs to change, to make sure we're using the appropriate radiation dose in the right setting," she said. "All of the radiology organizations talk about using the right dose in the right setting, and yet if you have no idea of the doses you're using, it seems like silly lip service. What dose are you using right now? What setting is this right now? You have no idea."
The latest amended text of AB 510 can be accessed at the California Legislation Information website.